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Phase II Trial of Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases

Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer, Breast Cancer, Progressive Breast Cancer

Thank you

Trial Information

Phase II Trial of Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases

- Participants will receive bevacizumab and carboplatin intravenously. In addition to
bevacizumab and carboplatin, participants whose cancer is positive for HER2 will
receive Herceptin intravenously. Herceptin is a standard treatment for patients with
HER2-positive breast cancer.

- The first treatment cycle lasts four weeks. Participants will receive bevacizumab on
Day 1 and carboplatin on Day 8. After the first treatment cycle, each treatment cycle
thereafter lasts three weeks and participants will receive bevacizumab and carboplatin
together on Day 1 of each cycle.

- Physical exams and vital signs will be performed and collected at multiple time points
during the participants first treatment cycle and at the beginning of each cycle

- Participants will have a brain MRI and MRA between days 2-4 of the first treatment
cycle and again at the end of the second treatment cycle for research purposes only.
These scans are mandatory and must be performed at the Massachusetts General
Hospital-Charlestown Navy Yard facility. A brain MRI will be performed every other
cycle after that (the end of cycles 2, 4, 6, 8, etc.). Participants will also have CT
or MRI scans of their body at the enof of every other treatment cycle.

- MUGA or ECHO scans will be done every 4 treatment cycles.

- Participants will have blood tests done on Day 8 of the first treatment cycle and at
the beginning of every treatment cycle thereafter to check blood cell counts and how
well their organs are functioning.

- A urine test will be done every other cycle (at the beginning of cycles 3, 5, 7, etc.)

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast cancer, with metastatic
disease. patients without pathologic or cytologic confirmation of metastatic disease
should have unequivocal evidence of metastasis by physical exam or radiologic study

- Measurable disease. Patients must have measurable CNS disease, defined as at least
one parenchymal brain lesion that can be accurately measured in at least one
dimension with longest dimension >/= 10mm by local radiology review

- New or progressive CNS lesions, as assessed by the patient's treating physician

- No increase in corticosteroid dose in the week prior to the baseline brain MRI

- 18 years of age or older

- Life expectancy of greater than 12 weeks

- ECOG performance status 0-2

- Normal organ and marrow function as outlined in the protocol

- Left ventricular ejection fraction >/= 50%, as determined by RVG or echocardiogram
within 60 days prior to initiation of protocol therapy

- Prior carboplatin is allowed if it was not given in conjunction with bevacizumab

- Prior trastuzumab is allowed

- No prior bevacizumab since diagnosis of CNS metastases or within 6 months prior to
diagnosis of CNS metastases

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation

Exclusion Criteria:

- Patients who have had chemotherapy within 14 days prior to entering the study, or
those who have not recovered adequately from adverse events due to agents
administered earlier

- Patients may not receive any concurrent investigational agents while on study

- Patients may not receive any cancer-directed concurrent therapy , such as concurrent
chemotherapy, radiotherapy, or hormonal therapy while on study. Concurrent treatment
with bisphosphonates is allowed

- History of Grade 3 or 4 allergic reactions attributed to compounds of similar or
identical biologic composition to bevacizumab, carboplatin, or trastuzumab

- Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker,
shrapnel, or ocular foreign body

- Leptomeningeal carcinomatosis as the only site of CNS involvement

- More than 2 seizures over last 4 weeks prior to study entry

- Grade 1 or higher CNS hemorrhage on baseline brain MRI

- History of grade 2 or higher CNS hemorrhage within 12 months of study entry

- Inadequately controlled hypertension

- Prior history of hypertensive crisis or hypertensive encephalopathy

- NYHA Grade II or greater congestive heart failure

- History of myocardial infraction or unstable angina within 6 months prior to day 1

- Significant vascular disease within 6 months prior to day 1

- History of hemoptysis within 1 month prior to day 1

- Evidence of bleeding diathesis or significant coagulopathy

- Current, ongoing treatment with full-dose warfarin or its equivalent

- Use of aspirin (>325 mg/day) within 10 days prior to day 1

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to day 1 or anticipation of need for major surgical procedure during the course
of the study.

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to day 1

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
day 1

- Serious, non-healing wound, active ulcer, or untreated bone fracture

- Proteinuria as demonstrated by a UPC ration >/= 1.0 at screening

- Known hypersensitivity to any component of bevacizumab

- Pregnancy or lactation

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Central nervous system (CNS) objective response, defined as either complete response or partial response

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nancy Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • Progressive Breast Cancer
  • carboplatin
  • bevacizumab
  • Breast Neoplasms
  • Neoplasm Metastasis



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617